2014-2018
Bachelor of Science in Pharmacy
Our Lady of Fatima University
More Info About Me
Hi! My name is Harlene. I am your Virtual Assistant who can be your partner in growing your business. I can track, manage, organize and strategize and edit pictures, GIFs and videos for your page on the social media platform.
My Skills and Competencies
Social Media Management
Data Entry
Content Creator
Certificates
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My Experience and Education
2022
-
2022
In.Corp Philippines
(Regulatory Affairs Officer)
• Ensures that LTOs and CPRs (Drug, Food, Cosmetics, HUHS, Medical devices) are up to date and in compliance with the regulatory requirements of the Food and Drug Administration (FDA)
• Prepares and facilitate applications, and renewal application of LTO registration for all licenses and products.
• Responds to policies implemented by FDA
• Performs quality assurance on all artwork and labels to ensure that they are in conformity with FDA requirements and gives clients advise on the regulation.
• Monitors and ensures compliance of documentation as part of customer requirements.
• Monitor advisories and updates concerning with regulatory requirements cascaded by the FDA
2021
-
2022
Medical Affairs Pharmacist
(Mergers Drugfil Corporation)
• Conducting in-house training of personnel in compliance with GMP, GDP, and other related topics
• Assist teammates in the preparation and submission of documents to the Food and Drug Administration (FDA) such as a License to
• Operate (LTO) and Product Registration
• Adhering to quality control procedures and standards related to products and submission of documents
• Keeping up to date on pertinent regulatory requirements and issues and cascading necessary information to management and other stakeholders as needed
• Coordinates with the Medical Director in maintaining the
• Pharmacovigilance system
• Oversees the entire repacking process to ensure compliance with established procedures and GMP standards as a Production Head
• Prepare and review batch manufacturing records
• Perform other pertinent tasks in Medical Department
2020
-
2021
Hizon Laboratories Inc.
(Quality Control Analyst)
• Conducts routine and non-routine analysis of ln-process and Finished
• Products according to Standard Operating Procedure
• Physical Testing of pharmaceutical products (Tablets, Capsules, Suspension, and Syrup)
• Chemical Testing of Samples (Titrations, Identification, Thin-Layer Chromatogram)
• Skilled in Instrumental Analysis (High-Performance Liquid
• Chromatography, UV-Vis Spectroscopy)
• Keeps working area including the laboratory apparatus safe and clean by strict compliance to Good Laboratory Practices
• Ensures proper documentation of raw data in the Analytical Report
• Performs other duties as required by team leader
My Services
Social Media Management
Analyzing engagement data, identifying trends in customer interaction and planning digital campaigns to build community.
Data Entry / Web Researcher
Search the Internet for information on a wide variety of topics.
Content Creator
Promote companies' products and services by developing copy for websites, social media, marketing materials.